Commission Implementing Regulation (EU) 2025/86 of 20 January 2025 correcting Implementing Regulation (EU) 2024/2189 as regards the summary of the biocidal product characteristics
Date: 2025-01-20
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, decontamination, market approval








L_202500086EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/86


21.1.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/86
of 20 January 2025
         
correcting Implementing Regulation (EU) 2024/2189 as regards the summary of the biocidal product characteristics
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:







(1)


On 22 April 2024, the Standing Committee on Biocidal Products (the ‘Committee’) expressed a positive opinion on a draft act granting a Union authorisation for the single biocidal product ‘ClearKlens wipes based on IPA’ including the Annex thereto providing the summary of the biocidal product characteristics (the ‘SPC’).












(2)


On 3 September 2024, Commission Implementing Regulation (EU) 2024/2189 (2) granting the authorisation was adopted and subsequently published, however without the SPC.












(3)


Implementing Regulation (EU) 2024/2189 should therefore be corrected to include the SPC.












(4)


In the interests of clarity and legal certainty, that correction should be made without delay and this Regulation should apply retroactively as the terms and conditions relating to the making available on the market and use of the single biocidal product ‘ClearKlens wipes based on IPA’ are defined in the SPC.












(5)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products delivered prior to the adoption of Implementing Regulation (EU) 2024/2189,





HAS ADOPTED THIS REGULATION:



Article 1
In Implementing Regulation (EU) 2024/2189, the text set out in the Annex to this Regulation is added as the Annex.


Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
It shall apply from 24 September 2024.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 20 January 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2)  Commission Implementing Regulation (EU) 2024/2189 of 3 September 2024 granted a Union authorisation for the single biocidal product ‘ClearKlens wipes based on IPA’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L, 2024/2189, 4.9.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2189/oj).




ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT

ClearKlens wipes based on IPA

Product type(s)

PT02: Disinfectants and algaecides not intended for direct application to humans or animals

Authorisation number: EU-0032009-0000

R4BP asset number: EU-0032009-0000

1.   ADMINISTRATIVE INFORMATION

1.1.   Trade name(s) of the product







Trade name(s)


ClearKlens IPA 70 % non sterile WW
ClearKlens IPA 70 % v/v wipes
ClearKlens IPA 70 % wipes
ClearKlens IPA 70 % wipes non sterile
ClearKlens IPA 70 % wipes non sterile VH1
ClearKlens IPA 70 % wipes VH1
ClearKlens IPA 70 % WW
ClearKlens IPA 70 % WW VH1
ClearKlens IPA 70 % non sterile wipes
ClearKlens IPA 70 % non sterile wipes VH1
ClearKlens IPA wipe
ClearKlens IPA Wipes
ClearKlens IPA WW
Divodes IPA WW
IPA 70 % v/v WW
IPA 70 % wipes
IPA 70 % WW
IPA 70 % WW VH1
IPA wipes
IPA WW
Divodes IPA Wipes
Soft Care IPA Desinfection Wipes
TASKI Sprint IPA Wipes
TASKI Sani IPA Wipes
TASKI Jontec IPA Wipes
TechniSat® DES
TexVantage™ DES
PolySat® DES
AlphaSat™ DES
ThermaSat DES
TechniScrub™ DES
HoneyComb® DES
AlphaSat™ 10 DES
ClearKlens IPA 70 % v/v WW
Suma IPA Wipes
Vectra Honeycomb 10
TechniSat DCO
TechniSat MDC
TexVantage DCO
TexVantage MDC
PolySat DCO
PolySat MDC
AlphaSat DCO
AlphaSat MDC
ThermaSat DCO
ThermaSat MDC
TechniScrub DCO
TechniScrub MDC
HoneyComb DCO
HoneyComb MDC
AlphaSat 10 DCO
AlphaSat 10 MDC




1.2.   Authorisation holder








Name and address of the authorisation holder


Name


Diversey Europe Operations B.V.




Address


Regulatory team Maarssenbroeksedijk 2 3542 DN Utrecht NL




Authorisation number


 


EU-0032009-0000





R4BP asset number



 


EU-0032009-0000




Date of the authorisation


 


22 January 2025




Expiry date of the authorisation


 


31 December 2034




1.3.   Manufacturer(s) of the product







Name of manufacturer


Diversey Europe Operations B.V.




Address of manufacturer


Maarssenbroeksedijk 2 3542DN Utrecht Netherlands (the)




Location of manufacturing sites







Diversey Europe Operations B.V. site 1 Avenida Conde Duque 5, 7 y 9; Poligono Industrial La Postura 28343 Valdemoro (Madrid) Spain




Diversey Europe Operations B.V. site 2 Strada Statale 235 26010 Bagnolo Cremasco (CR) Italy




Diversey Europe Operations B.V. site 3 Cotes Park Industrial Estate DE55 4PA Somercotes Alfreton United Kingdom of Great Britain and Northern Ireland (the)




Diversey Europe Operations B.V. site 4 Rembrandtlaan 414 7545 ZW Enschede Netherlands (the)




Diversey Europe Operations B.V. site 5 Morschheimer Strasse 12 D-67292 Kirchheimbolanden Germany

















Name of manufacturer


Flexible Medical Packaging Ltd




Address of manufacturer


Unit 8, Hightown, White Cross Industrial Estate LA1 4XS Lancaster, Lancashire United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Flexible Medical Packaging Ltd site 1 Unit 8, Hightown, White Cross Industrial Estate LA1 4XS Lancaster, Lancashire United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


Ardepharm




Address of manufacturer


Les Iles Ferays 07300 Tournon-sur-Rhône France




Location of manufacturing sites


Ardepharm site 1 Les Iles Ferays 07300 Tournon-sur-Rhône France













Name of manufacturer


Entegris Cleaning Process (ECP) S.A.S




Address of manufacturer


395 rue Louis Lépine 34000 Montpellier France




Location of manufacturing sites


Entegris Cleaning Process (ECP) S.A.S site 1 395 rue Louis Lépine 34000 Montpellier France













Name of manufacturer


Pluswipes Ltd




Address of manufacturer


Pywell Rd, Willowbrook East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Pluswipes Ltd site 1 Pywell Rd, Willowbrook East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


ITW Contamination Control BV




Address of manufacturer


Saffierlaan 5 2132 VZ Hoofddorp Netherlands (the)




Location of manufacturing sites


ITW Contamination Control BV site 1 Saffierlaan 5 2132 VZ Hoofddorp Netherlands (the)













Name of manufacturer


ITW Texwipe




Address of manufacturer


1210 South Park Drive 27284 North Carolina Kernersville United States (the)




Location of manufacturing sites


ITW Texwipe site 1 1210 South Park Drive 27284 North Carolina Kernersville United States (the)













Name of manufacturer


ITW Contamination Control (Wujiang) Co., LTD




Address of manufacturer


No 4660 Pangjin Road Wujiang Economic &amp; Technological Development Zone Suzhou, Jiangsu province 215021 Suzhou China




Location of manufacturing sites


ITW Contamination Control (Wujiang) Co., LTD site 1 No 4660 Pangjin Road Wujiang Economic & Technological Development Zone Suzhou, Jiangsu province 215021 Suzhou China




1.4.   Manufacturer(s) of the active substance(s)







Active substance


Propan-2-ol




Name of manufacturer


INEOS Solvents Germany GmbH




Address of manufacturer


Anckelmannplatz D-20537 Hamburg Germany




Location of manufacturing sites







INEOS Solvents Germany GmbH site 1 Shamrockstrasse 88 D-44623 Herne Germany




INEOS Solvents Germany GmbH site 2 Römerstrasse 733 D-47443 Moers Germany

















Active substance


Propan-2-ol




Name of manufacturer


Shell Chemicals Europe B.V.




Address of manufacturer


Postbus 2334 3000 CH Rotterdam Netherlands (the)




Location of manufacturing sites


Shell Chemicals Europe B.V. site 1 Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the)













Active substance


Propan-2-ol




Name of manufacturer


Exxon Mobil Chemicals




Address of manufacturer


Hermeslaan 2 1831 Machelen Belgium




Location of manufacturing sites







Exxon Mobil Chemicals site 1 4045 Scenic Hailway LA 70805 Baton Rouge United States (the)




Exxon Mobil Chemicals site 2 Southampton SO45 1TX Hampshire United States (the)

















Active substance


Propan-2-ol




Name of manufacturer


Novapex




Address of manufacturer


21 Chemin de la Sauvegarde 21 Écully Park CS 33167 69134 Écully France




Location of manufacturing sites


Novapex site 1 Rue Gaston Monmousseau 38556 Saint Maurice l’Exil France




2.   PRODUCT COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the product











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


active substance


67-63-0


200-661-7


63,1  % (w/w)




2.2.   Type(s) of formulation

XX: presaturated wipes
3.   HAZARD AND PRECAUTIONARY STATEMENTS







Hazard statements


H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear protective eye protection/face protection.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTRE if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice.
P403+P235: Store in a well-ventilated place. Keep cool.
P370+P378: In case of fire: Use water to extinguish.
P264: Wash hands thoroughly after handling.
P501: Dispose of contents to hazardous waste collection point in accordance with local regulations.
P405: Store locked up.




4.   AUTHORISED USE(S)

4.1.   Use description


Table 1


Use #1 PT02: Hard surface disinfectant – professionals – wiping







Product type


PT02: Disinfectants and algaecides not intended for direct application to humans or animals




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data




Field(s) of use


Indoor use
Ready-to-use (RTU) pre-saturated wipes for the disinfection of pre-cleaned non-porous hard surfaces in laboratories, cleanrooms and pharmaceutical and cosmetics manufacturing facilities.




Application method(s)


Method: Wiping using RTU pre-saturated wipes
Detailed description: —




Application rate(s) and frequency


Application rate: Use X per 0,5 m2. Where X is 1 wipe; for wipes with the size 20-46 cm × 38-68 cm 2 wipes; for wipes with the size 15-31 cm × 20-31 cm 3 wipes; for wipes with the size 15 cm × 15 cm 4 wipes; for wipes with the size 10 cm × 10 cm
Dilution (%): Ready-to-use
Number and timing of application:
Apply according to disinfection protocols up to 20 times a day
Contact time: allow to take effect for at least 5 minutes.




Category(ies) of users


Industrial; professional




Pack sizes and packaging material


Packaging:
Slider bag Polyethylene terephthalate (PET) / Low-density polyethylene (LDPE) / High-density polyethylene (HDPE) with co-extruded (COEX) barrier layer
Flexpack bag PET/LDPE/HDPE with COEX barrier layer
Bucket – HDPE
Tub – HDPE
Each package can contain between 5 to 500 wipes, the bucket (HDPE) can contain up to 1 000  wipes.
Wipes:
100 % Polyester
100 % Polypropylene
50/50 % Polyester/Cellulose or
45/55 % Polyester/Cellulose




4.1.1.   Use-specific instructions

Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection. Fold wipe in mid-air into quarter folds. Wipe in one direction with overlapping strokes. Wet the surface completely. Allow to take effect for at least 5 minutes.
Only use wet wipes. Close the package after use.
Dispose used wipes immediately after application into a closed container.
4.1.2.   Use-specific risk mitigation measures

See general directions for use.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
4.2.   Use description


Table 2


Use #2 PT02: Hard surface disinfectant – professionals – mopping







Product type


PT02: Disinfectants and algaecides not intended for direct application to humans or animals




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data




Field(s) of use


Indoor use
Ready to use (RTU) pre-saturated wipes for the disinfection of pre-cleaned non-porous hard surfaces in cleanrooms and pharmaceutical and cosmetics manufacturing facilities.




Application method(s)


Method: mopping using RTU pre-satured wipes
Detailed description: —




Application rate(s) and frequency


Application rate: Use X per 1 m2. Where X is 1 wipe for wipes with the size 25-38 cm × 38-68 cm; 2 wipes for wipes with the size 20-46 cm × 31-46 cm; 3 wipes for wipes with the size 15-23 cm × 20-28 cm;
Dilution (%): Ready-to-use
Number and timing of application:
Apply according to disinfection protocols up to 2 times a day
Contact time: allow to take effect for at least 5 minutes.




Category(ies) of users


Industrial; professional




Pack sizes and packaging material


Packaging:
Slider bag Polyethylene terephthalate (PET) / Low-density polyethylene (LDPE) / High-density polyethylene (HDPE) with co-extruded (COEX) barrier layer
Flexpack bag PET/LDPE/HDPE with COEX barrier layer
Bucket – HDPE
Tub – HDPE
Each package can contain between 5 to 500 wipes, the bucket (HDPE) can contain up to 1 000  wipes.
Wipes:






 


100 % Polyester










 


100 % Polypropylene










 


50/50 % Polyester/Cellulose or










 


45/55 % Polyester/Cellulose








4.2.1.   Use-specific instructions

Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection. Attach wipe onto the mopping tool. Wipe systematically with overlapping strokes. Wet the surface completely. Allow to take effect for at least 5 minutes.
Only use wet wipes.
Close the package after use.
Dispose used wipes immediately after application into a closed container.
4.2.2.   Use-specific risk mitigation measures

See general directions for use
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage


See general directions for use.

4.3.   Use description


Table 3


Use #3 PT02: Hard surface disinfectant – professionals – wiping (equipment and small surfaces)







Product type


PT02: Disinfectants and algaecides not intended for direct application to humans or animals




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data




Field(s) of use


Indoor use
Ready-to-use (RTU) pre-saturated wipes for the disinfection of equipment and small non-porous hard surfaces in facilities (including hospitals, nursing homes and medical practices)




Application method(s)


Method: Wiping using RTU pre-saturated wipes
Detailed description: —




Application rate(s) and frequency


Application rate: Use X per 0,5 m2. Where X is 1 wipe; for wipes with the size 20-46 cm × 38-68 cm 2 wipes; for wipes with the size 15-31 cm × 20-31 cm 3 wipes; for wipes with the size 15 cm × 15 cm 4 wipes; for wipes with the size 10 cm × 10 cm
Dilution (%): Ready-to-use
Number and timing of application:
Apply according to disinfection protocols up to 20 times a day
Contact time: allow to take effect for at least 5 minutes.




Category(ies) of users


Industrial; professional




Pack sizes and packaging material


Packaging:
Slider bag Polyethylene terephthalate (PET) / Low-density polyethylene (LDPE) / High-density polyethylene (HDPE) with co-extruded (COEX) barrier layer
Flexpack bag PET/LDPE/HDPE with COEX barrier layer
Bucket – HDPE
Tub – HDPE
Each package can contain between 5 to 500 wipes, the bucket (HDPE) can contain up to 1 000  wipes.
Wipes:






 


100 % Polyester










 


100 % Polypropylene










 


50/50 % Polyester/Cellulose or










 


45/55 % Polyester/Cellulose








4.3.1.   Use-specific instructions

Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection. Fold wipe in mid-air into quarter folds and wipe in one direction with overlapping strokes. Wet the surface completely.
Allow to take effect for at least 5 minutes.
Only use wet wipes.
Close the package after use.
Dispose used wipes immediately after application into a closed container
4.3.2.   Use-specific risk mitigation measures

See general directions for use.
Keep children away from treated surfaces until dried.
4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
5.   GENERAL DIRECTIONS FOR USE (1)

5.1.   Instructions for use

See use-specific instructions for use.
5.2.   Risk mitigation measures

The product must be applied only in a sufficiently ventilated room. The minimum air change rates required are:






—


8/h in laboratories










—


60/h in pharmaceutical and cosmetics manufacturing facilities










—


20/h in cleanrooms










—


1,5/h in other areas (including hospitals, nursing homes and medical practices)




Wear chemical resistant gloves consistent with European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). This is without prejudice to the application of Council Directive 98/24/EC (2) and other Union legislation in the area of health and safety at work. See section 6 for the full references.
Avoid contact with eyes.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Inhalation: May cause drowsiness or dizziness.
Eye contact: Causes severe irritation.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

Environmental precautions:

Shall not be released to the ground, watercourses, pipes and sewers. Do not allow to enter the drainage system.
Methods and material for containment and cleaning up. Absorb with liquid-binding material (sand, diatomite, universal binders, sawdust).
5.4.   Instructions for safe disposal of the product and its packaging

The product and its container must be disposed of in a safe way, in compliance with any relevant legislation on the disposal of hazardous waste. Perform disposal or incineration in accordance with the local legislation and requirements.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

2 years shelf life.
Keep only in original packaging.
Store away from direct sunlight and below 40 °C.
Store in a closed container.
6.   OTHER INFORMATION

The active substance concentration expressed as percent volume is 70 % v/v.
The full titles of the references in section 5.2 ‘Risk mitigation measures’ are: EN 374 – Protective gloves against dangerous chemicals and micro-organisms.
Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work.


(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.

(2)  Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11, ELI: http://data.europa.eu/eli/dir/1998/24/oj).



ELI: http://data.europa.eu/eli/reg_impl/2025/86/oj
ISSN 1977-0677 (electronic edition)